K890096 is an FDA 510(k) clearance for the BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG. This device is classified as a Urinary Drainage Collection Kit, For Indwelling Catheter (Class II - Special Controls, product code FCN).
Submitted by Medical Inventors Corp., Inc. (Orlando, US). The FDA issued a Cleared decision on July 14, 1989, 185 days after receiving the submission on January 10, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K890096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1989 |
| Decision Date | July 14, 1989 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCN — Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |